Regulation & Human Factors

Avoid expensive delays and confusion with a clear, step-by-step plan for regulatory submission. We translate complex rules into a tailored strategy for your specific technology.

• Bespoke Strategy Reports and Roadmaps: We provide up-to-date, customized guidance on the latest regulatory requirements for medical devices, IVDs, and digital health products.
  • Comprehensive strategy reports give bespoke advice on medical device classification as well as the process and documentation required to achieve regulatory approval in the UK, EU & USA.
  • Roadmaps provide an overview of the medical device/IVD regulations which apply in different markets and summarise the roles and responsibilities of key players including Competent Authorities, Notified Bodies/UK Approved Bodies and other Economic Operators (Manufacturers, Authorised Representatives (EU) and/or UK Responsible Person, Importers and Distributors).
• Digital Health Compliance: We provide specialised guidance on data protection and data security regulations, as well as clinical risk management and clinical safety standards for digital health products in the UK.
• Compliance with Global Standards: In partnership with our Medical Regulatory Associates, we are also able to provide dedicated services to achieve compliance with:
  • UK and EU MDR/IVDR, FDA and other global regulatory requirements.
  • Quality Management System (QMS) Development: We help you develop and implement a QMS to meet European, US and International standards (ISO 9001 / ISO 13485 / FDA Quality System Regulation).

Related Case Studies

Regulatory bodies increasingly require evidence that your product is safe and intuitive for its intended users. Incorporating Human Factors (Usability Engineering) early reduces design risks, prevents use errors, and accelerates regulatory approvals.

We guide you through the iterative Human Factors process, ensuring your device design is refined by its intended users—clinical staff, patients, and carers—in compliance with IEC 62366-1:2015/AMD 1:2020.

• Human Factors Planning and Strategy: We work with you to plan usability studies, identifying device user profiles, use environments, possible use errors, and realistic use scenarios and clinical tasks.
• Formative Evaluations (Risk Reduction): We design and conduct studies during the design phase to reduce risks and validate preferred design concepts. These studies with intended users (clinicians and/or patients) examine use errors, review safety implications, and assess the innovation’s overall ease of use.
• Summative Testing (Regulatory Requirement): We conduct the required usability testing on final products and product documentation (e.g. user manuals & IFUs).  This testing provides the critical evidence needed for your technical file submission prior to product launch, ensuring your path to final regulatory approval.